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Data / Medical devices / Collector, Ostomy

Collector, Ostomy (EXB): 54 FDA-registered makers in 18 countries

54 establishments in 18 countries are registered with the FDA to make Collector, Ostomy (product code EXB, Class 1, 21 CFR 876.5900). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 102 510(k) clearances under this code, the latest on October 6, 2025, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EXB
Device class
1
Regulation
876.5900
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
China15
United States14
United Kingdom4
Denmark3
Mexico3
Ireland2
Turkey2
Dominican Republic1
Australia1
Czechia1
Brazil1
Hungary1
Costa Rica1
Lithuania1
India1
Poland1
Latvia1
New Zealand1

Makers of Collector, Ostomy

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Convatec Dominican Republic, Inc.Haina San Cristobal, Dominican RepublicManufacturer1June 16, 1981000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomManufacturer1June 16, 1981000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer1June 16, 1981000api.fda.gov
Aeris Environmental LtdRosebery New South Wales, AustraliaManufacturer0000api.fda.gov
Alp Ecology S.R.O.Ostrava - Privoz Ostrava-Mesto, CzechiaComplaint file establishment, Manufacturer0000api.fda.gov
Aimi Health Technology (Guangdong) Co., Ltd.Dongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Casex, LtdaCuritiba Parana, BrazilManufacturer0000api.fda.gov
Coloplast (china) Ltd.ZHUHAI Guangdong, ChinaManufacturer0000api.fda.gov
Coloplast A/SHUMLEBAEK Hovedstaden, DenmarkSpecification developer0000api.fda.gov
Coloplast Hungary KFTTATABANYA Komarom-Esztergom, HungaryManufacturer0000api.fda.gov
Concarey Medical Technology Co., LtdShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Coloplast A/S - Mordrup SiteEspergaerde Hovedstaden, DenmarkManufacturer0000api.fda.gov
Coloplast Costa Rica SALa Lima, Guadalupe Cartago, Costa RicaManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesManufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Dongguan Hong De Medical Plastic Products Co. Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Furine ApsSkaevinge Hovedstaden, DenmarkManufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hollister ULCREHINS BALLINA Mayo, IrelandManufacturer0000api.fda.gov
Hubei Hendry Medical Appliance Co., LtdXiaogan City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hollister Lietuva UABKaunas district, LithuaniaManufacturer0000api.fda.gov
Hollister Medical India Private LimitedBawal, Rewari Haryana, IndiaManufacturer0000api.fda.gov
Jago-Pro SP. Z O.O.JAWORZNO Slaskie, PolandContract manufacturer0000api.fda.gov
Jiangsu Ostup Medical Products Co. Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kem Enterprises Acquisition, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Konfort Ozel Saglik Hizmetleri Tibbi Malz. San Ve Tic Ltd StiEskisehir, TurkeyManufacturer0000api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim SirketiSalihli Manisa, TurkeyManufacturer0000api.fda.gov
Kutol Products CompanySharonville, OH, United StatesContract manufacturer0000api.fda.gov
Lumaclean, LLCConcord, NC, United StatesSpecification developer0000api.fda.gov
Medical Molding & Manufacturing de Mexico S. de R.L. de C.V.Reynosa Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Nanjing Anjian Medical Device Co.,ltd.Nanjing Jiangsu, ChinaContract manufacturer0000api.fda.gov
Nuance Medical, LLCCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Ostoform LtdMullingar Westmeath, IrelandExporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Ostomy AssistClayton, MO, United StatesSpecification developer0000api.fda.gov
Pdi Emea LtdCorby Northamptonshire, United KingdomContract manufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Remedy Medical ManufacturingMesa, AZ, United StatesContract manufacturer0000api.fda.gov
Salts Healthcare LimitedAston Birmingham, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Sarasota Medical ProductsSarasota, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shaoxing Haoshide Medical Products Co.,ltdShaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
SIA Elas BalticJelgava, LatviaContract manufacturer0000api.fda.gov
SP-MeditecPeachtree City, GA, United StatesContract manufacturer0000api.fda.gov
Stomagienics, Inc.Greenville, SC, United StatesManufacturer0000api.fda.gov
Suzhou Kangyouwei Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
The Insides Company LimitedAuckland, New ZealandManufacturer0000api.fda.gov
Tongxiang Bao-Health Medical Instrument Co., Ltd.Tongxiang Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated October 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.